MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 7/0 (0,5) 45CM 2XDR8 CV RCP; CARDIAC SUTURE

Model Number C3090685

Device Problems Material Separation (1562); Material Integrity Problem (2978)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.K133890.Investigation: samples received: 36 unopened race-packs.Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market 396 units of this code-batch.There are no units in our stock.We have received 36 closed samples for analysis.We have tested the knot pull tensile strength of the samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 0.22 kgf in average and 0.198 kgf in minimum (ep requirements:.10 kgf in average and 0.036 kgf in minimum).Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.Remarks: when working with optilene® suture material, great care should be taken to avoid any crushing or crimping damage of the monofilament by instruments such as forceps or needle holders.Final conclusion: although the results of the samples received fulfil the specifications of european pharmacopoeia/ b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.No corrective/preventive actions needed.

Event Description

It was reported that the thread brakes.The reporter indicated that the thread brakes on several envelopes during surgery.No further information has been received.Patient information is not available.

• Brand Name: OPTILENE 7/0 (0,5) 45CM 2XDR8 CV RCP
• Type of Device: CARDIAC SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer (Section G): B/ BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer Contact: silvia orus ; carretera de terrassa, 121; rubi, barcelona 08191 ; SP 08191
• MDR Report Key: 9163885
• MDR Text Key: 172019089
• Report Number: 3003639970-2019-00696
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2023
• Device Model Number: C3090685
• Device Catalogue Number: C3090685
• Device Lot Number: 118264V004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1